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U.S. District Court Upholds Final Judgment for XIFAXAN(R) 550 mg That Prevents FDA Approval of Norwich's Abbreviated New Drug Application Until 2029
LAVAL, QC / ACCESSWIRE / May 17, 2023 / Bausch Health Companies Inc. (NYSE/TSX:BHC), and its gas...
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[{"type":"text","content":"U.S. District Court Upholds Final Judgment for XIFAXAN(R) 550 mg That Prevents FDA Approval of Norwich’s Abbreviated New Drug Application Until 2029LAVAL, QC / ACCESSWIRE / May 17, 2023 / Bausch Health Companies Inc. (NYSE/TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that the U.S. District Court of Delaware in the matter of Salix Pharmaceuticals, LTD et al v. Norwich Pharmaceuticals, Inc., has denied Norwich Pharmaceuticals' motion to modify the Court's final judgment that prevents the U.S. Food and Drug Administration (FDA) from approving Norwich's abbreviated new drug application (ANDA) for XIFAXAN® (rifaximin) 550 mg before Oct. 2, 2029. As a result of this decision, Norwich's ANDA cannot be approved until Oct. 2, 2029.\"This decision is important for patients who continue to depend on a proven and highly effective drug to treat gastro-intestinal disorders,\" Thomas J. Appio, Chief Executive Officer stated. \"It is our long-standing position that the XIFAXAN patent claims are valid and infringed by Norwich's ANDA. We will continue to advocate for the safety of patients who have benefited from the continued access to XIFAXAN, and we look ahead to the appeal process.\"To date, Norwich has not received tentative or final approval of its ANDA from the FDA.About XIFAXANXIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.About SalixSalix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.About Bausch HealthBausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversifi...